Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00239044 |
To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplant Recipients |
Drug: Enteric-coated Mycophenolate sodium (EC-MPS) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study to Evaluate the Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients |
Estimated Enrollment: | 40 |
Study Start Date: | December 2002 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Inclusion criteria
Exclusion Criteria
Study ID Numbers: | CERL080A2405NL01 |
Study First Received: | October 12, 2005 |
Last Updated: | May 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00239044 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Kidney transplant recipients; Enteric-coated Mycophenolate sodium (EC-MPS) |
Cyclosporine Mycophenolate mofetil Cyclosporins |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |